Jazz Pharmaceuticals’ Ziihera (ziipamig?—per provided text: Ziihera) received a label expansion from the FDA that moves the bispecific into a frontline regimen for certain HER2-positive gastrointestinal cancers, including gastric cancer. The expansion marks the first time the company expects Ziihera to be marketed to newly diagnosed patients. The drug’s earlier FDA clearance came via accelerated approval for later-line biliary tract cancer in 2024. In that setting, Ziihera generated $24.8 million in revenue in 2025, and analysts projected a substantially larger addressable opportunity for the expanded indication. In Jazz’s Phase 3 trial, combinations of Ziihera with chemotherapy—with or without immunotherapy Tevimbra—reduced progression or death risk by 35% versus a Herceptin plus chemo comparator, and reduced death risk by 28% in the death-specific analysis. Investors are now focusing on uptake and how broadly the new label supports reimbursement and adoption across HER2-expressing subgroups.